To Expand or Not Expand – That is the Question….Will FDA Approve Merck’s 4th Request to Expand Gardasil to 26 – 45 year old Women?


December 2, 2010

Leslie Carol Botha and Cynthia Ann Janak prepared an extensive power point for the FDA on HPV Vaccines Mechanisms of Action in Women – Endocrine Influence, HPV – Pre Testing and Immune System Involvement. The document was submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010.

The information included in the presentation has implications not only for female adolescent health – but for women ages 26 to 45 and older who may be the next age group for HPV vaccination approval.

December 3, 2010 – HPV Vaccine VAERS reports (women ages 9 to 26)

20,575 adverse reactions
352 reports of abnormal pap smears post vaccination.
89 reported deaths – plus 5 reports submitted to the FDA, missing from VAERS, uncovered via the Freedom of Information Act (FOIA) by Judicial Watch

Botha and Janak’s intent is to provide research and data to support the hypothesis that the HPV vaccines may even be more dangerous in an older age group with hope of preventing FDA approval of Merck’s 4th request to expand Gardasil use to older women.

The FDA declined to make a comment about the research presented – nor did they choose to listen to a verbal presentation – nor did they attempt to answer any questions raised by the research presented.  Instead Botha and Janak were told via email: The CBER team thanks you for the additional information since the last listening session.  At this point, they do not want to have any additional listening sessions, and instead will answer in writing any questions you may have.

Botha and Janak did respond with one additional question:

With the additional information that was presented will the CBER review team be looking at the possibility of suspending the license of the HPV vaccines pending further safety review?

Although acknowledgment was received that the question would be forwarded to CBER, a response has yet to be received.

HPV Vaccine Mechanisms of Action in Women has been converted to a 63 page PDF file (may take some time to download) filled with research and documentation on issues not considered during HPV vaccine clinical trials – nor in any other vaccine or medical trial for that matter.

With all of the studies coming out about the relevance the endocrine system has to women’s health – it is time that the menstrual cycle be given its due as the regulating system in a woman’s body.

Botha and Janak raised the following issues/questions in the HPV Mechanisms of Action Presentation: (Research, data, documentation and corresponding links are documented in the PDF file.)

Expanding Gardasil Use to 26 to 47 year old Women

  1. Adverse reactions to the HPV vaccines have for the most part been experienced by girls without pre-existing illnesses or diseases.  Many of those affected have had a family history of allergies or autoimmune conditions.  But other than that these girls have been high-functioning scholars and athletes.  We are concerned that adequate testing on the 26 to 47 year old age group of women has not been conducted to warrant the expansion of the HPV vaccines to this market.

How will the HPV vaccines affect women who have may have been previously exposed to HPV, who are prone to any of the above conditions due to hormone imbalances and a compromised immune system?

  1. In the CDC study Prevalence of high-risk human papillomavirus among older women, in a nationally representative population, nearly 1 in 16 women aged 57-85 was found to have high-risk HPV, and prevalence was stable across older age groups. These are high rates of numbers for an age group whose biological age may differ markedly from their chronological age.

Chronic Inflammation – Autoimmunity & Menopause

  1. In the past few years studies have suggested that chronic inflammation lies at the root of heart disease, cancer, osteoporosis, Alzheimer’s, and autoimmune diseases like rheumatoid arthritis and psoriasis, as well as other immune disorders.

Inflammation is a particularly important issue for women in perimenopause and menopause. Studies have shown that hormone transitions in premenstrual syndrome and menopause causes inflammation and could be a key reason why women suffer 75% of all autoimmune disease.

Existing chronic inflammation in combination with the HPV vaccine that may also causes inflammation due to unknown mechanisms of action should be of great concern to not only the FDA but to physicians as well.

Have independent studies been done in the 26 to 46 yr. age group under consideration for expansion of the HPV vaccine?  What are the HPV viruses prevalent in this demographic?  What will the interaction between the current vaccines be with other HPV strains in a body that is experiencing hormonal shifts associated with peri-menopause and menopause?

What studies were conducted to determine that this mechanism of action may cause not only immune system over-stimulation but also overstimulation of HPV if already present in the body prior to vaccination?

Poly Cystic Ovarian Syndrome PCOS

  1. PCOS affects as many as 1 out of 15 women. Often the symptoms begin in the teen years and are caused by changes in hormone levels.  The concern is that since “estrogen dominance” due to genetic and environmental factors is increasing and that adolescent girls are producing more estrogen during menarche and that estrogen stimulates histamine production – the additional
  2. L-histadine present in Gardasil may be a cause of further hormone imbalance that may lead to PCOS.  This overstimulation of estrogen and histamine may also be a cause of the two cases of ovarian cancer reported to VAERS.

Since menstrual cycle evaluation; i.e.; estrogen and histamine interaction/reaction – stimulation and overstimulation was not included in the clinical trials this mechanism of action affecting many of the girls adversely affected by the vaccine is of great concern.

Oral Contraceptive Use & Cervical Cancer

  1. The concern is: for non-contraceptive pill users HPV prevalence was higher in the follicular phase of the menstrual with estrogen dominance and histamine stimulation.  What studies have been conducted on the mechanisms of action of between estrogen, histamine and HPV prevalence?
  2. Studies on the efficacy of the HPV vaccines and oral contraceptives have been studied – but not about safety; Gardasil PPI 7.2 use with Hormonal Contraceptives, Cervarix PPI Interactions  7.2.

Since OC’s may increase the risk of cervical cancer – what is the mechanism of action between OC’s and HPV vaccines and potential stimulation HPV viruses other than 16 & 18?   Are studies being conducted > 5 years on the safety and efficacy of long term OC use and HPV vaccination?

Prevalence of other HPV Strains & HPV Vaccine Interaction

What studies have been conducted on HPV vaccines safety and efficacy if, according to CDC studies HPV viruses other than 16 & 18 are prevalent? What are the mechanisms of action between the vaccine and these other viruses?  Is it known that the mechanisms of action in the vaccine do not stimulate replication of the other viruses?

Have independent studies been conducted on the safety and efficacy of the interaction of the HPV vaccine with other HPV viral strains?

Have independent studies been done on the 26 to 46 yr. age group under consideration for expansion of the HPV vaccine?  What are the HPV viruses prevalent in this demographic?  What will the interaction between the current vaccines be with other HPV strains in a body that is experiencing hormonal shifts associated with perimenopause and menopause?

Hormone Imbalance & Estrogen Dominance

  1. Excess estrogen, (“estrogen dominance”) combined with low progesterone (lack of ovulation) is also a major trigger. Once again, estrogen plays a factor in hormone balance – in menopause – just as in menarche.  Estrogen dominance in conjunction with histamine production and the additional L-histadine in Gardasil and the mechanisms of action are of great concern.

Glutathione Deficiency

  1. As women age glutathione decreases hence there is an increase in disease as we age. Glutathione deficiency has been found in many auto-immune diseases like MS, ALS and CFS besides Autism.

Have any studies been done on the 26 – 46 yr. age group as to glutathione levels pre and post vaccination and if so what were the results?  What is the mechanism of action that could cause glutathione deficiencies after vaccination?

Once again, the question needs to be asked – have the appropriate studies on the 26 to 47 year old age group been conducted before HPV vaccine expansion into this market is approved? The same question, for that matter should also be asked for adolescent girls and boys and for administrative use in anal and oral cancers.

These are the questions. American medical consumers are still waiting for the answers.


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.